After opening a new site for undertaking Neuro-Spinal Scaffold Clinical Trial, Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) announced that it is reopening enrollment for subjects three to five for its Investigational Device Exemption (IDE) pilot study. The study aimed to investigate Neuro-Spinal Scaffold will enroll the three subjects parallel, that is, without maintaining a mandatory safety hold in between the enrollment of each subject.
Three subjects’ enrollment
Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) said that they have not across any serious safety concerns associated with the Neuro-Spinal Scaffold or its implant procedure in the first and second subjects. The company said that it has received due approval from both the U.S. Food and Drug Administration (FDA) as well as the Data Safety Monitoring Board (DSMB) to progress with the study.
No safety issue
The company’s CEO Mark Perrin took the opportunity to throw light on the company’s success with implants in the two subjects. He said that despite a multi-trauma injury and various complications, the second subject did not report any serious safety issue with the implantation of Neuro-Spinal Scaffold. He said that the company is targeting to enroll its remaining three to five subjects this calendar year, after which its pilot study will come to an end. Perrin spoke about the new exciting development this time as he said that the patients could be enrolled concurrently and that the company has expanded its reach to eight active clinical sites.
A day earlier, Invivo Therapeutics Holdings Corp (OTCMKTS:NVIV) had said that it has added Keck Hospital of University of Southern California in its list of clinical sites for its pilot study. It is to be noted that the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, AZ enrolled the first patient of the company. The Carolinas Medical Center in Charlotte took in the second subject.